Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy (REMOD-REVERT)
Heart Failure With Preserved Ejection Fraction
About this trial
This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction focused on measuring HFpEF, Heart failure, Cardiac Hypertrophy
Eligibility Criteria
Main Inclusion Criteria: Provision of signed informed consent prior to any study-specific procedures. Male or female of non-childbearing potential patients age ≥40 and <85 years. Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrollment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrollment with at least intermittent need for diuretic treatment. Ejection fraction ≥ 45% (determined by echocardiography at site laboratory) Increased intraventricular wall thickness (≥11 mm for female and ≥12 mm for male patients by echocardiography at site laboratory) NT-proBNP > 300 pg/ml (sinus rhythm); >900 pg/ml (atrial fibrillation at time of screening/inclusion or documented with the last 6 months) BMI between 22 kg/m² and 45 kg/m². Main Exclusion Criteria: Hemoglobin A1C (A1C) ≥10.5% eGFR <35 mL/min/1.73m² Systolic blood pressure (BP) <90 mmHg on 2 consecutive measurements at 5-minute intervals, at Screening. Systolic BP≥180 mmHg on 2 consecutive measurements at 5-minute intervals, at Screening. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
CDR132L 4.52 mg
Placebo
Six times CDR132L 4.52 mg/kg body weight intravenous in single dose.
Six times Placebo intravenous in single dose.